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George Mills

Throughout the 2015 AAMI conference in Denver June 6–8, staffers scrambled to expand room capacity on the fly as session audiences ballooned beyond the expected capacity—a byproduct of AAMI’s largest gathering to date. Correctly anticipating that George Mills’ update on Joint Commission (TJC) activities and the subsequent Q&A session would strain resources even further, the association preemptively relocated the sessions to the main ballroom, communicated in a last-minute Sunday night email. That was a relief for attendees who have been previously squeezed out of his standing-room-only sessions. Mills spoke about some of the most common issues The Joint Commission has observed in its visits to hospitals. Temperature, humidity, and ventilation concerns are a frequent problem as they overlap with facilities, and can contribute to mold growth and hospital-acquired infections. Each year approximately 700,000 patients in the United States come down with such an infection, Mills noted, and about 80,000 die. Endoscope reprocessing, also appearing on ECRI Institute’s list of Top 10 Patient Safety Concerns, should be a matter of concern for biomeds, Mills stressed. He urged attendees to visit central sterilization periodically to review sterilization procedures and look for potential sources of cross-contamination, such as used endoscopes being processed too closely to sterilized devices. Mills also returned to the Centers for Medicare and Medicaid Services’ (CMS) December 2013 memo on preventive maintenance and alternative equipment maintenance (AEM) programs, a document that continues to generate questions and confusion from HTM departments. The topic was clearly a source of interest for many attendees. According to CMS, Mills said, ambulatory surgery centers are not eligible for an AEM program, although critical access hospitals may implement one. He also clarified the distinction between TJC guidelines’ use of the term “high risk” versus CMS’ term “critical” equipment. “‘High risk’ is just me saying I’m not going to use the word ‘critical,’ ” Mills said. “Sorry for the confusion, but ‘high risk’ is exactly equivalent to CMS’ definition of ‘critical.” He further clarified that “high risk” has a broader definition than merely life support equipment. For example, defibrillators are not technically life support devices, since they are used to resuscitate patients, but they still stand to enable loss of life if they fail. Likewise, a surgical robot could also cause serious harm if it didn’t function properly. However, Mills warned, “Just because [a device is] high risk doesn’t automatically mean it’s high PM.” The AEM program option negotiated with CMS was designed to give biomeds “freedom to make rational decisions,” he said. “You have to use some common sense.” During the question and answer portion of his talk, Mills fielded several requests for clarification on specific aspects of the AEM program guidelines and advice for particular situations. For imaging equipment ineligible for an AEM program, deviating from OEM guidelines in almost any respect can be problematic. Doing PM procedures more frequently than required, or adding on a procedure that is not explicitly noted in the OEM guidelines, such as regularly defragmenting the PC associated with an ultrasound unit, must generally be either cleared by the OEM or considered alternative maintenance. Mills apologized, explaining, “We’re in this box.” In one case, an attendee asked about a device that uses ultrasound technology but that doesn’t deliver any therapy to patients. According to strict interpretation of CMS guidelines, such units must still be PMed according to OEM guidelines, Mills said. Mills also advised attendees to check out the ANSI/AAMI standard EQ89 as a high-level resource for building an HTM department and bringing up staffing levels. It’s “not a cookbook,” Mills said, but the document could provide helpful resources for HTM professionals.